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Self-help Application for Eating Disorder

Primary Purpose

Eating Disorder in Adolescents and Young Adults

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I (Prepectoral),
Arm II (Subpectoral)
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder in Adolescents and Young Adults

Eligibility Criteria

13 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 13-22 years Owns a smartphone Experienced at least one episode of binge eating over the past 4 weeks Exclusion Criteria: diagnosed with anorexia nervosa BMI ≤ 17.5 having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis

Sites / Locations

  • GangnamSeverance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

I (Prepectoral)

II (Subpectoral)

Arm Description

Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks

Waiting list Wait-list control(participants will use the smartphone app after the intervention phase) The waitlist group will receive treatment as usual, Patients from the waitlist group will be offered access to App after a 8-weeks period.

Outcomes

Primary Outcome Measures

Change in Eating Disorder Cognitions assessed using EDE-Q global scores
The global score of Eating Disorder Examination Questionnaire (EDE-Q) has the 28-item scale of key attitudinal and behavioral ED symptoms. Higher scores indicate higher eating disorder symptomology.

Secondary Outcome Measures

Change in concerns with body weight assessed using EDE-Q weight concern scores
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Change in concerns with body shape assessed using EDE-Q shape concern scores
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Change in restrained eating assessed using EDE-Q dietary restraint scores
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Change in concerns with eating assessed using EDE-Q eating concern scores
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Change in eating disorder symptoms assessed using the Eating Attitude Test
The Eating Attitude Test (EAT) is a 40-item, 6-point, self-report scale that measures dieting behaviors, food preoccupation, anorexia, bulimia, and concerns about being overweight. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.
Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale
The Yale Food Addiction Scale is a 35-item self-report inventory to identify people most likely to have an addiction to high-fat and/or high-sugar foods. The scale uses a combination of Likert and dichotomous scoring options. The YFAS provides two scoring options, a "symptom" count version that indicates the number of dependence symptoms experienced in the past 12 months and a "diagnostic" threshold that is met when three or more "symptoms" are present during the past 12 months and clinically significant impairment or distress is endorsed(Gearhardt et al., 2012).
Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children
The Yale Food Addiction Scale for Children(YFAS-C) is a 25-item, 5-point self-report scale with higher scores indicating more food addiction symptoms in children. Items 1 to 18 are rated on a 5-point Likert scale and Items 19 to 25 are rated on a dichotomous (0 = no; 1 = yes) scale.
Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale
The Difficulties in Emotion Regulation Scale(DERS) is the 36 items self-report scale to asks respondents how they relate to their emotions. Scores are presented as a total score as well as a score for each of the 6 subscales. Higher scores mean greater problems with emotion regulation.
Change in Depression symptoms assessed using the Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for assessing the severity of depression. The total score range from 0 to 63 and 0-9 indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression and 30-63: indicates severe depression.
Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety
Change in assessed the impact an eating disorder has on psychosocial functioning using The Clinical Impairment Assessment Questionnaire (CIA)
The Clinical Impairment Assessment questionnaire (CIA) is a 16-items self-report measure to assess psychosocial impairment resulting from eating disorder features. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment.
Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES)
The Rosenberg Self-Esteem Scale(RSES) is a A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The total score is from 0 to 30, with higher scores representing higher self-esteem.
Change in the body attitudes associated with desiring a thinner assessed using the Eating Disorder Inventory-2, Drive for Thinness
Drive for thinness (DT), a subscale of the Eating Disorder Inventory (EDI), is a self-report measure of disordered eating attitudes about body image, weight, and shape. The total score is from 0 to 21. Higher scores mean an excessive concern with dieting, preoccupation with weight, and fear of weight gain
Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale
The Eating Disorder Diagnostic Scale (EDDS) is a 22-item self-report questionnaire designed to measure eating disorders symptomatology
Change in the heart rate variability
The heart rate variabilities the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds. This measures only those who want it
Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS)
Functional near-infrared spectroscopy (fNIRS) is a tool to measure functional brain activities using the changes of optical absorption in the brain through the intact skull. This tool measures only those who want it, and the target number of participants is 40.

Full Information

First Posted
November 7, 2022
Last Updated
January 31, 2023
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05615090
Brief Title
Self-help Application for Eating Disorder
Official Title
A Randomized Controlled Trials of Self-help Application for Eating Disorder Through Multifaceted Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether mobile-based self-help CBT-E treatment for eating disorder can reduce eating disorder symptoms compared to the waitlist group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder in Adolescents and Young Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The waitlist group receives usual care for the first 8 weeks. After 8 weeks, the waitlist group begins the intervention and the immediate intervention group begins a maintenance phase
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I (Prepectoral)
Arm Type
Experimental
Arm Description
Participants received the Self-help app-based CBT-E for eating disorder for 8 weeks
Arm Title
II (Subpectoral)
Arm Type
Other
Arm Description
Waiting list Wait-list control(participants will use the smartphone app after the intervention phase) The waitlist group will receive treatment as usual, Patients from the waitlist group will be offered access to App after a 8-weeks period.
Intervention Type
Procedure
Intervention Name(s)
Arm I (Prepectoral),
Intervention Description
The intervention will be delivered through a smartphone app. The app provides users with ED symptom self-monitoring, psycho-education and relapse prevention in an evidence-based CBT-E.
Intervention Type
Procedure
Intervention Name(s)
Arm II (Subpectoral)
Intervention Description
The intervention will be delivered through a smartphone app. The app provides users with ED symptom self-monitoring, psycho-education and relapse prevention in an evidence-based CBT-E.
Primary Outcome Measure Information:
Title
Change in Eating Disorder Cognitions assessed using EDE-Q global scores
Description
The global score of Eating Disorder Examination Questionnaire (EDE-Q) has the 28-item scale of key attitudinal and behavioral ED symptoms. Higher scores indicate higher eating disorder symptomology.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Secondary Outcome Measure Information:
Title
Change in concerns with body weight assessed using EDE-Q weight concern scores
Description
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in concerns with body shape assessed using EDE-Q shape concern scores
Description
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in restrained eating assessed using EDE-Q dietary restraint scores
Description
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in concerns with eating assessed using EDE-Q eating concern scores
Description
EDE-Q subscales Higher scores indicate higher eating disorder symptomology.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in eating disorder symptoms assessed using the Eating Attitude Test
Description
The Eating Attitude Test (EAT) is a 40-item, 6-point, self-report scale that measures dieting behaviors, food preoccupation, anorexia, bulimia, and concerns about being overweight. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in addictive-like eating behaviors assessed using the Yale Food Addiction scale
Description
The Yale Food Addiction Scale is a 35-item self-report inventory to identify people most likely to have an addiction to high-fat and/or high-sugar foods. The scale uses a combination of Likert and dichotomous scoring options. The YFAS provides two scoring options, a "symptom" count version that indicates the number of dependence symptoms experienced in the past 12 months and a "diagnostic" threshold that is met when three or more "symptoms" are present during the past 12 months and clinically significant impairment or distress is endorsed(Gearhardt et al., 2012).
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in addictive-like eating behaviors assessed using the Yale Food Addiction Scale for Children
Description
The Yale Food Addiction Scale for Children(YFAS-C) is a 25-item, 5-point self-report scale with higher scores indicating more food addiction symptoms in children. Items 1 to 18 are rated on a 5-point Likert scale and Items 19 to 25 are rated on a dichotomous (0 = no; 1 = yes) scale.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in emotion regulation problems assessed using the Difficulties in Emotion Regulation Scale
Description
The Difficulties in Emotion Regulation Scale(DERS) is the 36 items self-report scale to asks respondents how they relate to their emotions. Scores are presented as a total score as well as a score for each of the 6 subscales. Higher scores mean greater problems with emotion regulation.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in Depression symptoms assessed using the Beck Depression Inventory
Description
The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for assessing the severity of depression. The total score range from 0 to 63 and 0-9 indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression and 30-63: indicates severe depression.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in anxiety symptoms assessed using the State-Trait Anxiety Inventory
Description
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. All items are rated on a 4-point scale. Higher scores indicate greater anxiety
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in assessed the impact an eating disorder has on psychosocial functioning using The Clinical Impairment Assessment Questionnaire (CIA)
Description
The Clinical Impairment Assessment questionnaire (CIA) is a 16-items self-report measure to assess psychosocial impairment resulting from eating disorder features. Possible scores range between 0 - 48, with higher scores indicating more impairment and lower scores indicating less impairment.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in self-esteem assessed using the Rosenberg self-esteem scale (RSES)
Description
The Rosenberg Self-Esteem Scale(RSES) is a A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The total score is from 0 to 30, with higher scores representing higher self-esteem.
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in the body attitudes associated with desiring a thinner assessed using the Eating Disorder Inventory-2, Drive for Thinness
Description
Drive for thinness (DT), a subscale of the Eating Disorder Inventory (EDI), is a self-report measure of disordered eating attitudes about body image, weight, and shape. The total score is from 0 to 21. Higher scores mean an excessive concern with dieting, preoccupation with weight, and fear of weight gain
Time Frame
Baseline, 8 weeks,16 weeks, 28 weeks
Title
Change in eating disorder symptoms assessed using the Korean version of the Eating disorder Diagnostic Scale
Description
The Eating Disorder Diagnostic Scale (EDDS) is a 22-item self-report questionnaire designed to measure eating disorders symptomatology
Time Frame
Baseline, 8 weeks,16 weeks
Title
Change in the heart rate variability
Description
The heart rate variabilities the physiological recordings of the variation in the time interval between consecutive heartbeats in milliseconds. This measures only those who want it
Time Frame
Baseline, 8 weeks,16 weeks
Title
Change in brain activities recorded with functional near-infrared spectroscopy (fNIRS)
Description
Functional near-infrared spectroscopy (fNIRS) is a tool to measure functional brain activities using the changes of optical absorption in the brain through the intact skull. This tool measures only those who want it, and the target number of participants is 40.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 13-22 years Owns a smartphone Experienced at least one episode of binge eating over the past 4 weeks Exclusion Criteria: diagnosed with anorexia nervosa BMI ≤ 17.5 having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EunJoo Kim
Phone
82-2-2019-4601
Email
ejkim96@yuhs.ac
Facility Information:
Facility Name
GangnamSeverance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EunJoo Kim
Phone
82-2-2019-4601
Email
ejkim96@yuhs.ac

12. IPD Sharing Statement

Citations:
PubMed Identifier
22684991
Citation
Gearhardt AN, White MA, Masheb RM, Morgan PT, Crosby RD, Grilo CM. An examination of the food addiction construct in obese patients with binge eating disorder. Int J Eat Disord. 2012 Jul;45(5):657-63. doi: 10.1002/eat.20957. Epub 2011 Aug 30.
Results Reference
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Self-help Application for Eating Disorder

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